21 C.F.R. § 522.995 Fluprostenol sodium injection.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of sterile aqueous solution contains fluprostenol sodium equivalent to 50 micrograms of fluprostenol. (b) Sponsor. See 000859 in §510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 0.55 microgram fluprostenol per kilogram of body weight. (2) Indications for use. The drug is used in mares for its luteolytic effect to control the timing of estrus in estrous cycling and in clinically anestrous mares that have a corpus luteum. (3) Limitations. Administer by intramuscular injection only. Warning: Not for use in horses intended for food. For veterinary use only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. In the early stages, women may be unaware of their pregnancies. Fluprostenol is readily absorbed through the skin and can cause abortion and/or bronchiospasms. Direct contact with the skin should therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water. [44 FR 52191, Sept. 7, 1979, as amended at 47 FR 22092, May 21, 1982]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.995 Fluprostenol sodium injection.
